by Hemostat is a medical device used by healthcare professionals during surgery to control bleeding. It acts by applying pressure to blood vessels or tissues to temporarily stop blood flow. Various types of hemostats are available in the medical field, including mechanical hemostats, chemical hemostats, and topical hemostats. Mechanical hemostats include clamps and clips that physically block blood flow. Chemical hemostats utilize substances that accelerate the blood clotting process. Topical hemostats are agents directly applied to tissues to induce clot formation.
Regulatory Framework for India Hemostat
The regulation of medical devices in India comes under the Drugs and Cosmetics Act, 1940 and Rules 1945. Hemostatic devices are classified as Class A medical devices that require to fulfill certain safety and quality standards before marketing and distribution within India. The Central Drugs Standard Control Organization (CDSCO) acts as the central drug authority for regulating and controlling the availability of all medical devices in the country. Manufacturers need to obtain a license from the state licensing authority and comply with Good Manufacturing Practices. Product certifications from US FDA, CE Mark, or ISO 13485 are commonly accepted for imported hemostats.
Popular India Hemostat Products
Some of the leading India Hemostat products available in the Indian market include:
– Surgicel – Absorbable gelatin sponge manufactured by Ethicon for topical application to control minor capillary, venous, and small arterial hemorrhages.
– Gelfoam – Porcine skin gelatin sponge developed by Pfizer as an absorbable surgical dressing to aid hemostasis.
– Avitene – Microfibrillar collagen sponge used as a local hemostatic agent by C.R. Bard.
– Hemostats (catridges and pads) – Absorbable oxidized cellulose-based products offered by Johnson & Johnson for compression hemostasis.
– TachoSil – Collagen-fibrin patch manufactured by Takeda used to reinforce sutures or seal tissues.
– Tisseel – Fibrin sealant glue containing fibrinogen and thrombin components launched by Baxter to adhere tissues.
India Hemostat: Domestic Production and Research
While several leading MNC brands dominate the India Hemostat, domestic production has also witnessed growth over the years. Companies like Anthropic, Palson Medical, and Surgipro have launched indigenously developed absorbable gelatin sponges, oxidized regenerated cellulose pads, and microfibrillar collagen powders for topical hemostasis. Ongoing research at academic institutions and the Council of Scientific and Industrial Research (CSIR) aims to develop novel herbal and biosynthetic hemostatic alternatives derived from plants and biomaterials. If successful, these alternatives could make hemostats more affordable and expand access for a wider patient population in India.
Increasing Role of Advanced Hemostats
With improvements in surgical techniques and interventions, the need for advanced hemostats to control complex bleeding cases has increased substantially. Newer generation hemostat products rely on advanced technologies like fibrin sealants, collagen-based composites, and absorbable syringes or pastes. Fibrin sealants mimic the natural coagulation cascade and form robust seals over bleeding sites. Collagen-reinforced composite patches provide mechanical strength in addition to biocompatibility. Absorbable sealants deliver hemostatic agents precisely to bleeding areas. Leading vendors have introduced India-specific versions of advanced fibrin and thrombin products, hemostatic matrices, and sealant delivery devices to support specialties like cardiothoracic, vascular, and trauma surgeries. With familiarity among surgeons growing, the role of advanced hemostats is expanding in managing severe bleeding scenarios.
Challenges and Future Outlook
While hemostats have enabled better surgical blood management over the years, certain challenges still remain in India. High costs continue to limit access, especially advanced variety, in a still developing healthcare system. Limited production scale and import dependence affect costs to a degree. Lack of specialized clinical training on proper selection and application of different hemostats leads to suboptimal results sometimes. However, with overall healthcare spending increasing, Indian government promoting domestic manufacturing, and greater awareness among providers, it is expected that effective and affordable hemostat options will become more widely available in both urban and rural areas. Ongoing research may alsoRESULT in cost-effective indigenous products suitable for Indian requirements. If these challenges are addressed, hemostats can play a bigger part in reducing surgical morbidity and mortality from blood loss.
*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
